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Propranolol Administration and Prevention of Child PTSD in Child Trauma Victims

Primary Purpose

Posttraumatic Stress Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inderol (propranolol)
Sponsored by
Kent State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Posttraumatic Stress Disorders focused on measuring posttraumatic stress disorder, propranolol, inderol, child, trauma, Posttraumatic stress disorders (PTSD)

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants consisted of 15 male and 14 female accidental injury patients aged 10-18 recruited from the emergency department of Akron Children's Hospital. - Eligibility criteria included a Glasgow Coma Scale (GCS) score of 14 or greater (to permit informed consent) and an "at-risk" child score on the STEPP (Winston, Kassam-Adams, Garcia-Espana, Ittenbach, & Cnaan, 2003), a screen for risk of PTSD.

Exclusion Criteria:

  • Medication-specific exclusion criteria included hypersensitivity to beta-blockers
  • Bradycardia
  • Cardiogenic or hypovolemic shock
  • Diabetes
  • Preexisting heart condition; OR
  • Treatment for asthma within the year prior to study entry (per Lacy, Armstrong, Goldman, & Lance, 2002).
  • Children were also excluded if they received epinephrine during emergency care or if they sustained any injuries precluding initiation of the propranolol regimen within 12 hours post-trauma.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    oral solution of propranolol (propranolol HCL 20 mg/5 ml solution) or a liquid placebo twice daily for 10 days (and taper for 5 days; based on Pitman et al, 2002). Dose was calculated as determined by Famularo et al. (1988) to be 2.5 mg/kg/d with a maximum dose of 40 mg bid (Green, 2001).

    A 25/5ml solution of placebo (a sugar solution that looks and tastes like the propranolol solution)

    Outcomes

    Primary Outcome Measures

    PTSD symptoms with the Clinician Administered PTSD Scale for Children and Adolescents (CAPS-CA)

    Secondary Outcome Measures

    cardiovascular reactivity during trauma description

    Full Information

    First Posted
    January 9, 2008
    Last Updated
    January 17, 2008
    Sponsor
    Kent State University
    Collaborators
    Akron Children's Hospital, Ohio Board of Regents
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00597389
    Brief Title
    Propranolol Administration and Prevention of Child PTSD in Child Trauma Victims
    Official Title
    The Efficacy of Early Propranolol Administration at Preventing/Reducing PTSD Symptoms in Child Trauma Victims: Pilot.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2004 (undefined)
    Primary Completion Date
    November 2005 (Actual)
    Study Completion Date
    February 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Kent State University
    Collaborators
    Akron Children's Hospital, Ohio Board of Regents

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Twenty-nine pediatric injury patients (ages 10-18) at risk for PTSD were randomly assigned to receive either propranolol or placebo in a double-blind placebo controlled design. Medication was initiated within 12 hours of hospital admission. At 6-weeks, child PTSD symptoms and heart rate (HR) during trauma recall were assessed. We hypothesized that participants who received propranolol would report fewer PTSD symptoms and have lower heart rates than those who received placebo.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Posttraumatic Stress Disorders
    Keywords
    posttraumatic stress disorder, propranolol, inderol, child, trauma, Posttraumatic stress disorders (PTSD)

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    29 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    oral solution of propranolol (propranolol HCL 20 mg/5 ml solution) or a liquid placebo twice daily for 10 days (and taper for 5 days; based on Pitman et al, 2002). Dose was calculated as determined by Famularo et al. (1988) to be 2.5 mg/kg/d with a maximum dose of 40 mg bid (Green, 2001).
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    A 25/5ml solution of placebo (a sugar solution that looks and tastes like the propranolol solution)
    Intervention Type
    Drug
    Intervention Name(s)
    Inderol (propranolol)
    Other Intervention Name(s)
    propranolol
    Intervention Description
    Children ingested a propranolol HCL 20 mg/5 ml solution twice daily for 10 days (and taper for 5 days). Medication was initiated within 12 hours post-trauma. Dose was calculated to be 2.5 mg/kg/d with a maximum dose of 40 mg.
    Primary Outcome Measure Information:
    Title
    PTSD symptoms with the Clinician Administered PTSD Scale for Children and Adolescents (CAPS-CA)
    Time Frame
    6-week follow-up
    Secondary Outcome Measure Information:
    Title
    cardiovascular reactivity during trauma description
    Time Frame
    at 6-week follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants consisted of 15 male and 14 female accidental injury patients aged 10-18 recruited from the emergency department of Akron Children's Hospital. - Eligibility criteria included a Glasgow Coma Scale (GCS) score of 14 or greater (to permit informed consent) and an "at-risk" child score on the STEPP (Winston, Kassam-Adams, Garcia-Espana, Ittenbach, & Cnaan, 2003), a screen for risk of PTSD. Exclusion Criteria: Medication-specific exclusion criteria included hypersensitivity to beta-blockers Bradycardia Cardiogenic or hypovolemic shock Diabetes Preexisting heart condition; OR Treatment for asthma within the year prior to study entry (per Lacy, Armstrong, Goldman, & Lance, 2002). Children were also excluded if they received epinephrine during emergency care or if they sustained any injuries precluding initiation of the propranolol regimen within 12 hours post-trauma.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Douglas L Delahanty, PhD
    Organizational Affiliation
    Kent State University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    Citation
    The efficacy of early propranolol administration at preventing/reducing PTSD symptoms in child trauma victims: Pilot. Nugent, Nicole Renee; Dissertation Abstracts International: Section B: The Sciences and Engineering, Vol 68(4-B), 2007. pp. 2665.
    Results Reference
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    Propranolol Administration and Prevention of Child PTSD in Child Trauma Victims

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